This safety-stop trochar device and system relates to an improvement in safety features for trochar assemblies [also referred to as trochar], and more particularly to a safety-stop, attachable to a trochar, registerable on a trochar, used on a trochar to permit puncture-movement of the trochar only to a pre-determined and pre-set depth, and interchangeability and concurrent or separate use of individual components therewith. These components include, but are not limited to, a drainage tube, a smoke evacuator, an obturator, and an illumination device each of which are adapted to be held securely in place during the course of a surgical procedure and thereafter as necessary or desired.
A trochar is sharp-pointed surgical instrument basically comprised of a stylet [the sharp cutting blades] and a cannula [a small tube for insertion into a body cavity or into a duct or vessel; also referred to herein as trochar tube or a sleeve] and is typically utilized to puncture a body cavity. The stylet is removably housed in the cannula and after the body cavity is punctured, the stylet is removed leaving the cannula in place and in communication with the body cavity whereby endoscopic, and similar, instruments can then be inserted through the cannula and into the body cavity.
Specific forms of minimally invasive surgical procedures include endoscopic and laparoscopic surgery which typically involve using small incisions and optical instrumentation being inserted into the body cavity. Endoscopy refers to video-assisted surgery that is performed through several small incisions rather than a single large incision. Laparoscopy is endoscopy that is done in the abdominal cavity.
The primary instrument used for the incisions necessary in these procedures is the trochar. The use of the trochar for these procedures greatly reduces the amount of cutting required in the course of surgery and, concomitantly, reduction of stress to the body. Reduction of stress to the body generally leads to faster recoveries and lower medical costs. Great care, however, must be exercised when performing such body cavity punctures with the trochar as the trochar blades are ‘surgically’ sharp and the exertion of manual force is required for the blades to pierce and go through the skin and abdominal wall of the patient.
A primary purpose of our safety-stop trochar device and system is to prevent the sharp trochar blades from accidentally being inserted too deeply. The inherent act of inserting the trochar and attempting to place it where desired requires applying a great deal of initial force down toward the deep anatomic structures, without being able to visualize them, then by sensing a loss of resistance, discontinuing the thrust.
All of this is generally done within a fraction of a second. Patient tissue-variability, in thickness and strength, further complicates the estimation of how much force is required, and for how long, to attain safe penetration.
Excess force, however minimal, or unforeseen factors within the body cavity could lead to piercing or cutting internal organs or other internal structures which could lead to inadvertent and severe life-threatening surgical complications. It has been known that some surgeons extend and use their finger, placed along the sleeve of the trochar, as a makeshift stop. This is awkward, inaccurate, and dangerous.
Trochars manufactured with shielded tips covering the blades; i.e., a safety shield, provide some aid in preventing inadvertent second cuts. While shielded trochar systems vary in their design, all generally have a spring-loaded retractable shield that covers the cutting tip on the blades of the trochar. The shields are either retracted prior to placement of the trochar in the wound or automatically retract during the placement. Once the sharp tip of the trochar's blades penetrates an abdominal wall and enters the abdominal cavity, the spring-loaded safety shield automatically deploys, covering the cutting tip and locking in place.
Theoretically, this prevents or decreases the incidence of damage to the bowel and the major vessels. Injuries can still occur, however, if the trochar is not used properly, if there is a malfunction of the safety shield, or with the presence of bowel adhesions to the anterior abdominal wall. Even with this improvement to the trochar, insertion of the primary trochar blades still remains a blind procedure.
Laparoscopy is a very commonly performed procedure throughout the world. In the U.S. alone, some 6 million cases are performed annually. The total number of cases is growing, as more specialties (general surgery, urology, gynecology) convert procedures over to the laparoscopic approach. Notwithstanding the safety features developed over the years for the trochar, laparoscopy has a background serious complication rate of approximately three to five per 1,000, due to trochar placement. These include intestinal damage, bladder damage, and most seriously large blood vessel (vascular) injury. Of the vascular injuries, which stand at one to two per 1,000, approximately 23% will die.
The majority of serious injuries occur when the stylet of the trochar, with cannula attached, is inserted too deeply, damaging the deeper structures within the body. Only 5 cm. maximum length is necessary, to enter the peritoneal cavity at the umbilicus, the most common entry site. However, trochars are 12 to 15 cm. in length, as a one size-fits-all device. The deep structures, most significantly major blood vessels, can be damaged at 7 to 10 cm, depending on the size of the patient, the degree of gas insufflation raising the abdominal wall, and the angle of thrust executed by the health-care provider.
Our safety-stop trochar device and system will function to reduce injuries and deaths to patients undergoing laparoscopic surgery. It will aid the health-care provider during the surgical procedure after one or more trochar incisions for internal surgery are made by:
a. applying a smoke evacuator to yet another of our safety-stop trochar device and system to remove smoke from the cavity which, in many laser and electro-surgical procedures, generate smoke and thereby obstructs the surgeon's vision;
b. applying a drainage tube to another of our safety-stop trochar devices and systems to effect drainage of fluids from the peritoneal cavity for post-operative evacuation of fluids;
c. applying a obturator to any one of our safety-stop trochar devices and systems after completion of surgery to thereby leave an incision unhealed and permit access into the cavity for viewing of post-operative results without the need to make another trochar incision or to force entry into the cavity from a closed and partially healed prior incision;
d. applying an illumination device to one of our safety-stop trochar device and system and into the cavity upon which surgery is being performed to provide much need full lighting of the peritoneal cavity to the surgeon;
e. inclusion of an adhesive on the underside of the base; and
f. addition of U-shaped extensions on the cap to facilitate securing to the base.
During Laparoscopic surgery the surgeon is often called upon to use electro-surgical instruments for cutting and/or cauterizing inside the peritoneal cavity. Because these instruments are essentially burning the flesh, they create a great deal of smoke that limits the already limited visibility a surgeon has when viewing the procedure through a laparoscope. Now, a shortened smoke evacuator cannula can be placed through a trochar and secured by our safety-stop device/trochar system [base 110, insert 140, and cap 130] in place. This would be like maintaining a vacuum hood over a range while cooking, which can be activated periodically. Current technology typically requires a smoke evacuator to be grasped, fed through the trochar, activated, removed from the cannula, and replaced where it won't fall off the surgical field. This process is repeated numerous times throughout the surgical procedure.
This entire new system to include a smoke evacuator is designed to allow the surgeon a hands-free way to evacuate smoke from the peritoneal cavity during surgery using the safety-stop trochar device/system as a platform. Anything that can be done to improve this view has the potential of shortening the surgical procedure, saving operating room time (saving money) and saving lives. The current method of evacuating smoke from the peritoneal cavity is to have an additional set of hands holding the tube in a spot dictated by the surgeon. The smoke evacuator of our present inventive system will eliminate the need for this costly person.
The addition of a drain holder [in conjunction with an insert of approximately ±3 MM) was also fashioned into this new system. Many surgeries entail placement of drains, usually hollow Jackson-Pratt type drains, to remove accumulating blood or pus or serious drainage over the critical one to four day post-operative period. These drains generally are sutured to the skin, which is NOT ideal when infection and pus are present, as is often the case. Our safety-stop device and entire new system, with the adhesive base, can secure the drains more optimally and provides a secure base to which a drainage tube can be attached. It requires only that the safety-stop trochar device/system be provided with one 1-2 additional inserts to fit the common sizes of drainage tubes.
The current method of attaching a drainage tube is insecure and often un-sterile and can be accidentally pulled out. Many complications occur because sutures have to be placed in an area of the body that may be contaminated by pus. For aesthetic reasons, many patients find suture scars undesirable. The Adhesive back of the safety-stop trochar device/system flange provides a secure platform for inserting the drainage tube and eliminates the need for stitches when holding it in place. Our original safety-stop device, in itself is a unique device and the drainage tube holder is designed to supplement it, as a complete system in a way that makes it even more unique in it's design and overall function.
When performing laparoscopic surgeries, up to five trochars can be used to make incisions in the lap for the laparoscope or any of the surgical instruments. It is often desirable to have a “second look” within hours to days after the initial surgery is performed. The purpose of these second looks is to re-enter and check for correct healing, possible infections, proper drainage of the abdominal cavity and other post-operative complications. The current method of taking these second looks is re-enter one of the ports into the lap that were made during the initial surgery by removing the stitches that were used to close the incision.
This requires an un-stitching and mechanical re-opening of the incision which may have already partially healed. Surgeons have indicated a need to have an easier way to re-enter the original incision made by the trochar for a second look.
This sterile obturator, placed through a laparoscopic port incision, and secured by a safety-stop trochar device/system, allows maintaining a laparoscopic port. Indications may include expected re-operation in one to three days, or irrigation of an intra-abdominal or pelvic abscess. During the period between the initial surgery and the second look, the incision may begin to heal and is often partly closed when the surgeon removes the stitches.
The inclusion of an obturator in the present system provides a method by which an it can be inserted into the peritoneal cavity with relative ease and as unintrusively as possible. It can be made of any plastic, thermoplastic, rubber, metal, urethane or polymer and can be installed in less than a minute permitting easy entry for the surgeon to place a scope for a second look and obviates the need for stitching and un-stitching the incision which is partially healed. It does not impede performance of the remainder of the surgery.
When performing laparoscopic surgeries, the peritoneal cavity in insufflated with gas creating a balloon-like dome in the peritoneal cavity in which to operate. Currently lighting for laparoscopic surgery is quite rudimentary. Typically the surgeon dedicates one hand to pointing the light on a scope at a particular object he/she wishes to see. This is like shining a flashlight in an empty room and only seeing the desk or like entering a room with a flash light without full overhead lighting when it is preferable to turn on the overhead light and see everything.
The addition of an illumination device into the present safety-stop trochar device/system greatly facilitates the vision for a surgeon. The illumination device can be a short light, such as a LED light or any conventional fiber optic light, to illuminate the peritoneal cavity. This would be either placed through a short trochar, or passed through the surgical port site, after the trochar created the opening, and was removed. This could create greater, more uniform illumination of the surgical field, with all the associated benefits of accuracy, decreased surgeon fatigue and less shadowing. Also, the heavy fiber optic light cord could be eliminated, and a better laparoscope could evolve, which did not include a light channel running through it, which sacrifices camera lens space and capacity.
This illumination concept was primarily designed to allow the surgeon a hands free way to illuminate the entire peritoneal cavity through the use of a corded or battery powered light that uses the safety-stop trochar device/system as a platform.
These structures and features were not conceived and, therefore, not mentioned in our prior, above-referenced, patent applications. From use of our safe-stop device described in those prior patent applications, we have discovered additional needs which currently are not met by any prior art device or our co-pending prior patent applications.
As with our co-pending applications, our safety-stop trochar device and system can be made of any material though, for cost considerations, any form of plastic or, particularly for the base wings, pliant plastic is best suited. Furthermore it can, but need not, be disposable for further patient safety as a one-time use.
As in our co-pending patent application, the base of our safety-stop trochar device and system also has a plurality of wings [extensions] as a base support and at least one aperture adjacent to the ends of the wings. The purpose of this structure is to permit the user to secure the base to the patient by suturing the base to the patient through the apertures on the wings. This more effectively and efficiently secures the base to the patient thereby freeing up the user's hand by not requiring the user to steadily hold the base onto the patient without movement; a difficult position to maintain.
What our co-pending applications did not conceive until now was a less intrusive alternative to suturing; an adhesive substance on the bottom of the wings is included to thereby permit a user to merely clean a patient's skin and directly apply the base to the skin. The adhesive secures the base to the skin without need of suturing.
In a co-pending application, a flexible base was addressed and described which allows the correspondingly inserted trochar a full range of motion, restriction that a rigid base may impose. The flexible base, in combination with the addition of an adhesive base presents a more useful and adaptive device. Securing the safety-stop trochar device/system to the patient eliminates trochar dislodgement, which frequently occurs with instrument exchanges, and which frequently leads to loss of the CO2 gas which is holding up the anterior abdominal wall. This is a significant setback to surgical progress, and has some risk in addition to the inconvenience. The adhesive base allows another non-invasive option, in addition to suturing, to secure the safety-stop trochar device/system to the patient.
The wings may be comprised of any material but it has been found that if the wings are rigid, in use the wings tend to cause bruising to the patient. A thermoplastic material or a thermoplastic rubber material is best suited for the construction of the base and the wings. It has been found that wing pliability affords a user greater flexibility of placement of the safety-stop trochar device and system and minimize, if not eliminate, bruising a patient. Depending on where a trochar is to be used on a patient, angling of the safety-stop trochar device and system may be necessitated. The pliability of the base and wings, due to the materials of which they are composed, also facilitates placement, angling, and safe and more exacting use of the safety-stop trochar device and system and trochar attached to it.
The safety-stop trochar device and system also facilitates introduction of surgical instruments through the tube upstanding from the base without fear of excess movement by the user. The base, sutured to the patient or secured by the adhesive, holds fast, without movement, facilitating the procedures to follow.
Also in our co-pending patent applications it was not conceived, and consequently not described, of use of a wing-nut type concept for the cap with U-shaped protrusions extension outward from the cap; the protrusions being on opposite side of each other. Two such protrusions are ideal but three or four may also function well.
In our co-pending application, typically an external object, such as a wrench, is used to secure the cap to the base, thereby adding compression to the insert so as to secure the device onto the cannula of the trochar. Personal experience and anecdotal data gathered from other surgeons have led applicants to seek an alternative method of securing the safety-stop trochar device/system without the use of a wrench.
The foregoing has outlined some of the more pertinent objects of the safety-stop trochar device and system. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the safety-stop trochar device and system. Many other beneficial results can be attained by applying the disclosed safety-stop trochar device and system in a different manner or by modifying the safety-stop trochar device and system within the scope of the disclosure.
Accordingly, other objects and a fuller understanding of the safety-stop trochar device and system may be had by referring to the summary of the safety-stop trochar device and system and the detailed description of the preferred embodiment in addition to the scope of the safety-stop trochar device and system defined by the claims taken in conjunction with the accompanying drawings.